The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia

NCT05494307 | Unknown Phase 2

• 1 other identifier: PKU-ITP039
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Overall response

  Achieving a platelet count ≥ 30 × 10\^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.

  From date of randomization until 1 years or the end of follow-up

Secondary Outcomes (11)

• Sustained response

  From date of randomization until 1 years or the end of follow-up

• Complete response

  From date of randomization until 1 years or the end of follow-up

• Remission

  at 12-month follow-up

• Time to response

  From date of randomization until 1 years or the end of follow-up

• Duration of response

  From date of randomization until 1 years or the end of follow-up

Study Arms (2)

Terbutaline plus danazol

EXPERIMENTAL

Terbutaline: A dose of 2.5 mg three times daily for 16 weeks Danazol: A dose of 200 mg twice daily for 16 weeks

Drug: Terbutaline; Drug: Danazol

Danazol monotherapy

ACTIVE COMPARATOR

Danazol: A dose of 200 mg twice daily for 16 weeks

Drug: Danazol

Interventions

Terbutaline DRUG

Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks

Terbutaline plus danazol

Danazol DRUG

Orally danazol at a dose of 200 mg twice daily for 16 weeks

Danazol monotherapy; Terbutaline plus danazol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation;
• Platelet counts \<30×10\^9/L or platelet counts \< 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
• Willing and able to sign written informed consent.

You may not qualify if:

• Pregnant or lactating women;
• Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);
• Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);
• Severe medical condition (lung, heart, hepatic or renal disorder);
• Patients who are deemed unsuitable for the study by the investigator.
• Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Terbutaline; Danazol

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiao-Hui Zhang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye-Jun Wu, MD

CONTACT

13522338836; wyejun1999@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: February 28, 2024
• Last Updated: August 9, 2022

Record last verified: 2022-08